Inside the FDA's New Office in China

The FDA, under immense pressure from Congress and the public to increase oversight of Chinese firms that manufacture products for drug- and devicemakers, established an office in Beijing last year. Since making the announcement, the FDA has provided little information about what the agency staff is doing there.

Who works in the office? What are the staff’s responsibilities? How are they organized? Are they finding and correcting violations? Is it now more expensive to contract with Chinese companies? Is the FDA slowing down imports?

Get the answers to these and many more questions …

In this 90-minute Encore presentation, Raymond Bonner of Sidley Austion, will give you the benefit of his interactions with the FDA staff in Beijing as he explains what they do, what they inspect and what they are finding. In addition, he’ll explain what it means now to outsource to, or import from, China. Sidley Austin is the first international law firm to establish a stand-alone, comprehensive food and drug regulatory practice in China.

If you ever wanted a first-hand account of what’s happening in China, you must register now for this exciting webinar. Sign up your entire team to listen in and discover:

The mission and organizational structure of the FDA’s China office — including who, what, where, when and how the office operates

What the responsibilities of the staff are (inspecting facilities or products ready for export?)

Analysis of the regulatory actions and sanctions they have taken or violations they have found to date

Drug and device firms’ experiences with the new system

Whether the FDA’s actions are making outsourcing to China less cost-effective

Stop wondering what the FDA’s China office is doing and find out from an expert who knows. Register nowandyou'll get an opportunity to ask your toughest questions during the Q&A session.

This presentation is a must for anyone doing business with Chinese suppliers, including:

Compliance officers

Executive management

General/corporate counsel

Regulatory/legislative affairs

Operations

Manufacturing

Purchasing

QA/QC

Outside consultants and attorneys

Raymond Bonner is a partner in the Sidley Austin Washington, D.C. office and is chair of the firm's FDA Regulatory and Enforcement practice. He previously served as a federal prosecutor in the District of Maryland for six years, where he prosecuted major pharmaceutical fraud and GMP cases, and litigated other FDA-related cases. He concentrates his practice on FDA -related cases. He has substantial litigation, enforcement, internal investigation, and compliance experience throughout the life sciences industry, particularly with grand jury and False Claims Act matters. He also counsels pharmaceutical and medical device companies regarding regulatory reporting and submission requirements, GMP/QSR and marketing matters.

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